FDA Inspection
IVFMD - Advanced Reproductive LaboratoryIVFMD - Advanced Reproductive Laboratory – FDA Inspection, Jun 4, 2019
Record Details
This FDA Inspection record concerns IVFMD - Advanced Reproductive Laboratory, with an inspection on June 4, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · f6fd1595-912e-4664-b6b4-3e628f71a98c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1091933
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 1271.85(b)(2)SOP for release; reactive for CMV
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.55(c)Name and personal info on accompanying records
Full citation text and observation details available on the Dashboard.
Other FDA inspections of IVFMD - Advanced Reproductive Laboratory
5| Date | Classification | Office | Project area |
|---|---|---|---|
| August 25, 2025 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 16, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| June 30, 2015 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 30, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 1, 2012 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for IVFMD - Advanced Reproductive Laboratory
- FDA Inspection 1279855 - 2025-08-25
- FDA Inspection 1163350 - 2022-02-16
- FDA Inspection 937295 - 2015-06-30
- FDA Inspection 932643 - 2015-06-30
- FDA Inspection 765576 - 2012-02-01
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